CEREBROLYSIN 10 ml. 5 ampoules
1 ml contains 215.2 mg Cerebrolysin concentrate, with ~ 15% are low molecular weight peptides and free amino acids -85%.
3. PHARMACEUTICAL FORM
Solution for injection / concentrate for solution for infusion.
4. CLINICAL PARTICULARS
• Organic, metabolic and neurodegenerative disorders of the brain, particularly senile dementia of the Alzheimer type.
• Ischemic stroke.
• head trauma, post-operative trauma, shock or injury of the brain.
4.2. Dosage and method of administration
Once can be applied up to 50 ml, as recommended course of therapy.
Optimal course of treatment consists of daily administration for a total duration of 10-20 days.
General recommendations for daily intake:
• organic and metabolic diseases of the brain, and neurodegenerative diseases (dementia): 5-30 ml
• ischemic stroke: 10-50 ml
• cranial trauma: 10-50 ml
• in children: 1-2 ml
The efficacy of the therapy can be enhanced by repeated treatment courses to achieve a further advantageous effect. After the initial rate, the dosing frequency may be reduced to 2 or 3 times a week. Between successive courses should have a period without administration of the product, identical in duration of the course.
Can be administered up to 5 ml intramuscularly and 10 ml undiluted intravenously. Doses of 10 ml to 50 ml should be administered by slow intravenous infusion after dilution with the suggested standard infusion solutions. The duration of infusion should be between 15 and 60 minutes.
For more than 24 hours at room temperature and light, has been tested with the following infusions:
- 0 9% sodium chloride (9mg NaCl / ml)
- Ringer (Na + 153,98 mmol / l, Ca2 + 2,74 mmol / l, K + 4,02 mmol / l, Cl-163,48 mmol / 1)
- 5% glucose solution
Possible use of vitamins and cardiovascular drugs simultaneously with Cerebrolysin, -but should be avoided mixing in a syringe Cerebrolysin with other medicinal products.
• Hypersensitivity to any component of the product.
• Severe renal failure.
4.4. Special warnings and precautions for use
Must be taken when:
• allergic diathesis
• epileptic conditions and grad mal seizures; seizures may be increased following treatment with Cerebrolysin®; there is no evidence that treatment with Cerebrolysin violates renal function, but the use of the medicinal product should be administered in the presence of severe renal insufficiency.
Based on the pharmacological profile of Cerebrolysin, you should pay particular attention to potential additive effects when co-administered with antidepressants or MAO inhibitors. In these cases it is recommended to reduce the dose of antidepressants.
Cerebrolysin should not be mixed with balanced amino acid solutions in an infusion.
4.6. Pregnancy and lactation
In studies with experimental animals did not show any evidence of reproductive toxicity. Not enough data are available for humans. Therefore, Cerebrolysin® should be used during pregnancy and lactation in the case that the potential beneficial effects outweigh the potential risks.
4.7. Effects on ability to drive and use machines
Clinical tests with Cerebrolysin no evidence of influence on the ability to drive and use machines.
4.8. Undesirable effects
Interference from the immune system
Very rare (<1 / 10,000)
Hypersensitivity or allergic reactions such as itchy skin, local inflammation, headache, neck pain, pain in extremity, fever, pain, dyspnoea, chills and shock-like state.
Rare (> 1 / 10,000- <1 / 1,000): loss of appetite.
Rare (> 1 / 10,000- <1 / 1,000) desired therapeutic effects were associated with agitation (aggressiveness, confusion, insomnia).
Disorders of the nervous system
Rare (> 1 / 10,000 - <1 / 1,000) in rapidly injected may have a feeling of dizziness.
Very rare (<1 / 10,000) after administration of Cerebrolysin observed occasionally grand mal.
Very rare (<1 / 10,000) in rapidly injected palpitations or arrhythmia.
Very rare (<1 / 10,000) were recorded cases of dyspepsia, diarrhea, constipation, nausea and vomiting.
Skin and subcutaneous tissue disorders
Rare (> 1 / 10,000- <1 / 1,000):
In rapidly injected may occur feeling of warmth or sweating.
General disorders and administration site conditions
Very rare ( 10,000) have been reported redness and burning.
In clinical studies reported rare (> 1 / 10,000, <1 / 1,000) of hyperventilation, high blood pressure, low blood pressure, fatigue, tremor, depression, apathy, drowsiness and flu symptoms (eg, cold, cough, infections respiratory tract).
The above side effects are typical for adults and can be observed without the use of medicine.
No episodes of damage to health due to overdose or intoxication.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Proteolytic peptide fraction obtained from pig brain stimulate cell differentiation, supports the function of nerve cells and enhances the protection and repair mechanisms. In studies with laboratory animals found that Cerebrolysin directly influences neuronal and synaptic plasticity that enhances the learning process. This has been shown in young, adult and elderly animals with reduced cognitive abilities. In experimental models of cerebral ischemia was found Cerebrolysin reduced the infarct, inhibited edema formation, stabilized microcirculation doubled the survival rate, and normalized lesion neurological deficits, and deficits in terms of learning opportunities. Marked positive results were also obtained using models of Alzheimer's disease. Besides the direct effect of Cerebrolysin with respect to the neurons, the product significantly increases the number of molecules which carry out the transport of glucose across the blood-brain barrier, thereby balancing the critical energy deficits associated with the disease.
Quantitative EEG studies in healthy volunteers and in patients with vascular dementia, after a four-week course of treatment have shown dose-dependent effects of increased neuronal activity (increase in alpha and beta frequencies). Regardless of the cause of the disease, whether neurodegenerative dementia of the Alzheimer type or vascular dementia, Cerebrolysin, lead to objectively improve skills training and activities of daily living. Just two weeks after the drug showed improvement in overall clinical condition, which is more pronounced with continued therapy. Regardless of the type of dementia, approximately 60-70% of patients respond positively to treatment with Cerebrolysin. In senile dementia of the Alzheimer type improvement in the clinical condition of the patient is maintained after the end of active treatment. In particular, are improved and stabilized for a long period of time, activities of daily living and consequently reduces the need for care and patient monitoring. On the basis of the neurotrophic effect of Cerebrolysin (factor-like nerve growth), the treatment may result in a substantial reduction, and in some cases to stop the progression of neurodegenerative processes.
5.2. Pharmacokinetic Properties
Proteolytic peptide fraction obtained from porcine brain consists of short biological peptides similar or identical to those produced endogenously. Until now it has been successfully direct determination of pharmacokinetic properties. Indirect pharmacokinetic data have been based on the pharmacodynamic profile of Cerebrolysin®. According to these data, there was a neurotrophic activity of the product within 24 hours after a single administration.
Furthermore, the components of the drug can cross the blood-brain barrier. Preclinical in vivo experiments demonstrated that intracerebroventricular administration of or peripheral Cerebrolysin, pharmacodynamic effects on the central nervous system are identical. Thus, indirect evidence for the passage of components of Cerebrolysin the blood-brain barrier.
5.3. Preclinical safety data
Acute toxicity / LDso
Male rats 68 ml / kg of body weight iv
Female rats 74 ml / kg of body weight iv
Dogs male / female> 52,2 ml / kg body weight iv
Rats: more than 5 ml / kg body weight for 26 weeks: moderate changes in hematology.
Dogs after administration of a maximal dose of 9 ml / kg body weight / day for 28 days (corresponding to about 10 times the human therapeutic dose), and through the application of a maximum dose of 4.5 ml / kg body weight / day for 26 weeks (corresponding to approximately 5 times the human therapeutic dose) was not established systematic intolerance associated with the product.
With intravenous Cerebrolysin doses toxic to the mother, and in the application of the highest possible volume, no teratogenic effects in any phase of reproduction in rats or rabbits, impact on fertility, reproduction, seed, embryotoxic and fetotoxic effects.
In in vitro or in vivo experiments Cerebrolysin not genotoxic or mutagenic potential.
None of the studies of chronic toxicity or clinical use of the product, no evidence of carcinogenic effects.
The peptides of higher molecular weight with antigenic potential have been removed from the infusion solution in the processes of production and quality control.
In immunological studies there was no effect on the immune system. Following these studies, it has been shown that the application of Cerebrolysin not lead to the formation of antibodies and of cutaneous anaphylaxis. Cerebrolysin no histamine-stimulating potential and no haemagglutinating effect.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Sodium hydroxide and Water for Injection.
Cerebrolysin is incompatible with solutions that change the pH (5.0 to 8.0) and a lipid-containing solutions.
6.3. Expiration date
6.4. Special storage conditions
Cerebrolysin should be stored at room temperature (below 25 ° C) and protected from light, store in a box and do not freeze.
Remove the solution from the vials before use.
6.5. Packaging Data
Ampoules amber glass Type I (Ph.Eur.) A nominal capacity of 1 ml, 5 ml and 10 ml.
6.6. Instructions for use
Administration of Cerebrolysin by venous catheter for long-term use, it must be washed with physiological sodium chloride solution before and after drug administration.
For single use only.
Use only clear, amber solution.